Status:
RECRUITING
Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Cerebral Venous Thrombosis
Anticoagulants and Thrombotic Disorders
Eligibility:
All Genders
18-80 years
Brief Summary
The goal of this observational study is to learn the safety and efficacy of edoxaban and rivaroxaban in Chinese population with the age range from 18 to 80 years who take edoxaban or rivaroxaban to tr...
Eligibility Criteria
Inclusion
- Patient aged from 18 to 80 years and no gender preference;
- Diagnosis of CVT as confirmed on MRBTI/MRV or CT/CTV or DSA;
- Acute or subacute CVT from onset to door within 4 weeks;
- The treating clinician irrelevant to the study is of the opinion that the patient is appropriate for edoxaban or rivaroxaban;
- Patient or legally authorized representative is able to give written informed consent.
Exclusion
- Patient refuse to take edoxaban or rivaroxaban to treat CVT;
- Pregnancy or breastfeeding women at the time of enrollment, or women who plan to get pregnant during study;
- Patient is anticipated to require invasive procedure (e.g. thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation;
- CVT secondary to central nervous system infection or severe head trauma;
- It is in the proliferative stage of malignant tumors currently or within 6 months of diagnosis;
- Bleeding diathesis or other contraindication to anticoagulation;
- Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use;
- Concomitant use of strong CYP3A4 or P-gp inhibitors;
- Impaired renal function (CrCl\<30 mL/min using Cockcroft-Gault equation) or investigator anticipate the CrCl lower than 30 mL/min during study;
- Impaired liver function (ALT or AST exceeds twice the normal upper limit) or diagnosed as acute hepatitis currently;
- Patient is unable to swallow due to depressed level of consciousness or other reasons;
- Patient has a severe or fatal comorbid illness with life expectancy less than 6 months;
- Patient with severe hypertension (SBP≥180mmHg and/or DBP≥110mmHg);
- Patient is known to be allergic to edoxaban or rivaroxaban.
Key Trial Info
Start Date :
April 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1486 Patients enrolled
Trial Details
Trial ID
NCT06947707
Start Date
April 10 2025
End Date
December 31 2027
Last Update
April 27 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053